Evidence map›Paper›PMID 29439395›Full record

Trial reportNutrients2018

Effectiveness and Safety of a Probiotic-Mixture for the Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial with Fecal Real-Time PCR and NMR-Based Metabolomics Analysis.

Maria Elisabetta Baldassarre, Antonio Di Mauro, Silvio Tafuri, Valentina Rizzo, Maria Serena Gallone, Paola Mastromarino, Daniela Capobianco, Luca Laghi, Chenglin Zhu, Manuela Capozza and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01869426 (Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01869426 phase4unknown statusnot on this map

Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time

TypeinterventionalSponsorPoliclinico HospitalRan2013 to 2015Enrolled62ConditionsInfant ColicsArmsVSL#3 drops, VSL#3 drops placebo
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Review
  7. Probiotics in Functional Gastrointestinal Disorders.Advances in experimental medicine and biology · 2024
    Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Birth Weight and the Development of Functional Gastrointestinal Disorders in Infants.Pediatric gastroenterology, hepatology & nutrition · 2020
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Maria Elisabetta BaldassarreNeonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. mariaelisabetta.baldassarre@uniba.it.ORCID 0000-0003-0590-6664
Antonio Di MauroNeonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. antonio.dimauro@uniba.it.ORCID 0000-0001-7052-9784
Silvio TafuriSection of Hygiene, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. silvio.tafuri@uniba.it.
Valentina RizzoNeonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. rizzo.vale@libero.it.
Maria Serena GalloneSection of Hygiene, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. serenagallone@gmail.com.
Paola MastromarinoDepartment of Public Health and Infectious Disease, "Sapienza" University of Rome, 00100 Rome, Italy. paola.mastromarino@uniroma1.it.
Daniela CapobiancoDepartment of Public Health and Infectious Disease, "Sapienza" University of Rome, 00100 Rome, Italy. daniela.capobianco@uniroma1.it.
Luca LaghiDepartment of Agro-Food Science and Technology, University of Bologna, Piazza Goidanich 60, 47522 Cesena, Italy. l.laghi@unibo.it.ORCID 0000-0003-1593-7376
Chenglin ZhuDepartment of Agro-Food Science and Technology, University of Bologna, Piazza Goidanich 60, 47522 Cesena, Italy. chenglin.zhu2@unibo.it.
Manuela CapozzaNeonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. manuela.capozza@uniba.it.
Nicola LaforgiaNeonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70100 Bari, Italy. nicola.laforgia@uniba.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo investigate the effectiveness and the safety of a probiotic-mixture (Vivomixx

methodsA randomized, double-blind, placebo-controlled trial was conducted in exclusively breastfed infants with colic, randomly assigned to receive a probiotic-mixture or a placebo for 21 days. A structured diary of gastrointestinal events of the infants was given to the parents to complete. Samples of feces were also collected to evaluate microbial content and metabolome using fecal real-time polymerase chain reaction (qPCR) and Nuclear magnetic resonance (NMR)-based analysis. Study registered at ClinicalTrials.gov (NCT01869426).

resultsFifty-three exclusively-breastfed infants completed three weeks of treatment with a probiotic-mixture (

conclusionsAdministration of a probiotic-mixture appears safe and reduces inconsolable crying in exclusively breastfed infants.

Indexed as

Breast FeedingColicCryingDouble-Blind MethodFecesFemaleHumansInfantInfant, NewbornMagnetic Resonance ImagingMaleMetabolomicsParentsProbioticsQuality of LifeReal-Time Polymerase Chain Reactioninfantile colicmetabolomicsmicrobiotaprobiotics

Identifiers

PMID29439395
PMCPMC5852771

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.